Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03456089

Enrollment

100

Registered

2018-03-07

Start date

2018-04-15

Completion date

2028-12-30

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Neurogenic, Urodynamics

Keywords

urodynamics, neurogenic, bladder

Brief summary

The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.

Detailed description

For patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. This monitoring is currently done by in-office urodynamics testing (UDS). This testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions. This study utilizes a novel pressure monitoring device which is portable and hooks to the end of a standard urinary catheter. The investigators will be investigating if this device can achieve similar pressure measurements as UDS. The investigators hope is that this device will provide similar measurements to UDS, and can be developed as a home bladder-pressure monitoring tool. This study will enroll children with neurogenic bladder who are currently undergoing UDS as part of their regular care. The measurements will be taken as part of the standard UDS protocol (with insertion of the UDS catheter) and will then be compared to the values obtained with UDS testing.

Interventions

DIAGNOSTIC_TESTUrodynamics Testing

Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 99 Years

Healthy volunteers

Inclusion criteria

* must have diagnosed neurogenic bladder * undergoing urodynamics testing as part of routine clinical care

Exclusion criteria

-None

Design outcomes

Primary

Measure	Time frame	Description
Bladder Pressure	During UDS testing	Pressure of the bladder at bladder capacity

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChris Cooper, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026